Postprandial Response of Fresh-squeezed and Processed Orange Juice of Lean and Obese Subjects

NCT03032120 | Completed DMC

• 1 other identifier: SaoPSU17
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aimed investigated the acute intake effect of fresh-squeezed orange juice (FOJ), processed orange juice (POJ), and an isoenergetic orange-flavored drink (control) on postprandial response of blood serum biomarkers (glucose, insulin, leptin and adiponectin), anti-oxidatant status, and prospective food intake in lean and obese subjects.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Assessment of the changes on glucose, insulin, leptin, and adiponectin levels over the time times 0, 30, 60, 120, and 300 min

  Determination of glucose, insulin, leptin, adiponectin in the blood serum.

  Up to 6 month after blood collection of glucose, insulin, leptin, and adiponectin.

Secondary Outcomes (2)

• Assessment of the changes on blood serum antioxidant biomarkers before and after each beverage intervention

  Up to 6 month after blood collection of antioxidant biomarkers (TBARS and ABTS).

• Assessing of change on prospective food intake after each beverage intervention

  Up to 3 weeks after the application of each 24-h food recall.

Study Arms (3)

Fresh orange juice

EXPERIMENTAL

Intervention: The subjects drank 5 mL/kg body weight of fresh-squeezed orange juice (FOJ).

Dietary Supplement: Orange juice

Processed orange juice

EXPERIMENTAL

Intervention: The subjects drank 5 mL/kg body weight of processed orange juice (POJ).

Dietary Supplement: Orange juice

Control

EXPERIMENTAL

The subjects drank 5 mL/kg body weight of control drink compounded by water mixed with sugars in a similar concentration of orange juices (5.2% of sucrose, 2.5% of fructose, 2.1% of glucose, 0.75% of citric acid, and malic acid 0.25%, flavored and colored with some drops of orange essence).

Dietary Supplement: Control

Interventions

Orange juice DIETARY_SUPPLEMENT

Lean and obese subjects drank one single dose (5 mL/kg body weight) of fresh-squeezed orange juice (FOJ) and processed orange juice (POJ) followed by an ad libitum breakfast. A washout period of seven days among each beverage (FOJ, POJ and control) was applied.

Fresh orange juice; Processed orange juice

Control DIETARY_SUPPLEMENT

Lean and obese subjects drank one single dose (5 mL/kg body weight) of an energy and sugars-matched orange-flavored drink (control), followed by an ad libitum breakfast. A washout period of seven days among each beverage (FOJ, POJ and control) was applied.

Control

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men and women volunteers;
• Volunteers with BMI between 18.5 to 39.9 kg/m2.

You may not qualify if:

• Volunteers with BMI between more than 40 kg/m2;
• Smokers volunteers;
• Volunteers who are in treatment with drugs (except contraceptives), vitamins and nutritional supplements;
• Volunteers who are dieting for weight loss;
• Volunteers who gained or lost more than 3 kg of weight in the last 3 months;
• Volunteers who consume more than 20 g of alcohol per day
• Volunteers who practicing intense physical activity (more than 5 hours per week).

Sponsors & Collaborators

• São Paulo State University: lead

Related Publications (1)

• Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.

  PMID: 11234459 RESULT

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 16, 2017
• First Posted: January 26, 2017
• Study Start: July 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: February 2, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share